- Only liver metastases with stable disease or clinical response to prior systemic
therapy for a period of at least 3 months are eligible

- Not more than 3 metastases, each measuring 3 cm or less in diameter

- Solitary liver metastasis smaller than 5 cm in diameter located in the periphery
of ventral segments (Sg 2-6)

- Peritoneal metastases

- Sugarbaker's peritoneal cancer index (PCI) will be used to assess peritoneal
tumour burden 28. The completeness of cancer resection (CCR) will be assessed by
the surgeon at the end of CRS; CCR-0 no macroscopic residual tumour, CCR-1 no
residual tumour nodules greater than 2.5 mm, CCR-2 residual tumour nodules larger
than 2.5 mm in diameter.

- Partial gastrectomy can be performed either by proximal or distal gastrectomy dependent
on tumour location and size

- Total gastrectomy is performed in patients with signet-ring cell cancers or linitis
plastica

- Tumour-draining lymph nodes are removed Pancreatic adenocarcinoma

- Tumours located in the head of the pancreas and with radiologic or macroscopic vascular
invasion, which need vascular reconstruction at the time of surgery, are treated by LAT
at ablation temperature of 90°C

- Tumours located in the head of the pancreas without radiologic or macroscopic vascular
invasion are treated by pancreaticoduodenectomy or LAT at 90°C

- Tumours located in the body or tail of the pancreas are treated by resection or LAT of
90°C

- Tumour draining lymph nodes are removed

o Liver metastases

- Tumours up to 3 cm are treated by LAT (RFA or MWA)

- Solitary tumour measuring 3 - 5 cm is treated by resection

- Superficial peripheral liver metastases (any diameter up to 5 cm) are allowed to be
resected

- HIPC is administered immediately after CRS: cisplatin at a dose of 100 mg/m2 is
dissolved in 3 litres of normal saline heated to less than 41° Celsius and infused into
the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60
minutes. Surgical reconstruction (anastomoses) is performed after HIPC.

- Time-points for cytokine and immunophenotyping analyses: before surgery (d-1), at
the end of surgery (d0), day after (d1) and at day 7 following CRS+HIPC

3. Gene-expression of primary and metastatic pancreatic cancer

- To better understand cancer biology and search for novel diagnostic and
therapeutic targets, fresh tissue samples from the primary tumour and from
metastases will be stored in RNA-later for RNA-extraction and future analyses.
Hereto, samples obtained from biliary, gastric, and pancreatic cancer tissue will
be stored. Based on the fact that pancreatic cancer is associated with the worst
prognosis, and based on our ongoing research on this disease, gene expression
studies in the current project will be focused on pancreatic cancer.

- In close collaboration with the department of pathology, we have stored
snap-frozen tissue samples from surgically resected human pancreatic cancer for
future research. Clinical, histopathological, and survival data of over 200
patients are registered in our database. Tissue samples (primary and metastases)
from the current study will be analysed together with available 96 primary tumour
samples that have already been controlled to be representative for high quality
RNA studies. These samples are obtained from patients with early and advanced
localized pancreatic cancer in various tumour stages. Gene-expression studies will
be performed using Affymetrix HG U133 Plus 2.0 arrays on primary and metastatic
tissue samples. These experiments will be conducted in close collaboration with
the microarray facility of VIB at KUL.

Outcome Measure:

Outcome Description:

Statistical methodology. The study is designed to have at least 80% power to detect a 40% increase in 1-y OS common to all strata (gastric-biliary-pancreas) after CRS+HIPC. The reference percentages 1-y OS are 52%, 37% and 34% for gastric, biliary and pancreatic cancer, respectively. An exponential distribution is assumed for the event times in the study group with a parameter yielding 72.8%, 51.8% and 47.6% 1-y OS in the mentioned strata.
Cancer-specific survival will be monitored using consecutive CT- and/or MRI-scan every 3 months after CRS+HIPC.

Outcome Time Frame:

1 year follow-up

Safety Issue:

No

Principal Investigator

Baki Topal, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Leuven

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

HIPCUpp-trial

NCT ID:

NCT01116791

Start Date:

July 2010

Completion Date:

August 2013

Related Keywords:

Peritoneal Carcinomatosis

Gastrointestinal Cancer

cytoreductive surgery

peritoneal chemotherapy

cisplatin

cancer

gastric

biliary

pancreas

peritoneal metastases

liver metastases

peritoneal carcinomatosis from upper gastrointestinal cancer

Fever

Carcinoma

Gastrointestinal Neoplasms

Name

Location

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